Study of the meningococcal ACW135 polysaccharide vaccine

Phase 1

• Conditions: Meningococcal Disease, Meningococcal Meningitis; Meningococcal Infections; Meningococcal Meningitis; Meningitis, Meningococcal; Meningitis, Bacterial; Bacterial Infections; Central Nervous System Bacterial Infections; Central Nervous System Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections

• Registration Number: RPCEC00000203
• Lead Sponsor: Finlay Institute, Center for Research, and Productions of Serum and Vaccines.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

1. Healthy adult of both sexes, with ages between 18-35 years old.
2. Good state of physical and mental health established by medical opinion by means of anamnesis and physical exam, before beginning the study.
3. Voluntary nature expressed by means of written informed consent.

Exclusion Criteria

1. Presence of acute disease (with or without fever) previous to the moment of their incorporation to the study.
2. Axilar temperature equal to or higher than 37.5 Celcius degrees immediately before the administration of the treatment.
3. Any suspicious or confirmed condition of immunodeficiency including positive diagnostic of HIV.
4. To have suffered meningococcal disease.
5. Therapy history with immunoglobulin during the 30 previous days to the administration of the vaccines included in the study
6. To be under immunosuppressive treatment (more than 14 days) or another type of medication that modifies the immunologic state, excluding the topical steroids or by inhalation.
7. Administration of a vaccine not planned in the Protocol, 30 days before the beginning of the study.
8. Pregnancy or lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety:<br>Serious Adverse Events (SAEs) related to the vaccine (anaphylactic reaction, temperature higher than 40oC, hypotension, bronchospasm, glottis edema, convulsions). Measuring time: 1, 2, 3, 4, 5, 6, 7, 15 28 days after vaccination.<br>Reactogenicity: <br>Local Adverse Events (Pain in the injection site, redness in the injection site, induration in the injection site). Measuring time: Day 1,2,3,4,5,6,7, 15 and 28 after vaccination<br>General Adverse Events (Fever, Malaise, Headache and somnolence). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination.<br>Description of the unexpected adverse events (Adverse Event name). Measuring time: 7, 15 and 28 days after the vaccination.<br>Intensity of adverse events (Mild, moderate, or severe). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination. <br>Adverse events with causality relationship (related, unrelated). Measuring time: Day 1, 2, 3, 4, 5, 6, 7, 15 and 28 after vaccination.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity<br>- Seroprotection (Bactericidal antibody titers = 1:8). Measuring time: at baseline and 28 days after vaccination. <br>- Bactericidal antibody seroconversion (Increase of at least 4 times the bactericidal antibodies titers). Measuring time: at baseline and 28 days after vaccination.<br>- Bactericidal Antibodies Geometric mean titers in serum samples. Measuring time: at baseline and 28 days after vaccination.